25 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MODEL 8500, HAND HELD PULSE OXIMETER, MODEL 8500
FDA 510(k)
FDA Class 2
·Cardiovascular
Preat
FDA UDI
Preat Corporation·00842092170267·Biomet 3i Certain®-compatible 6.0mm Engaging Ve...
3i Certain
FDA UDI
Preat Corporation·00842092104569·Biomet 3i Certain®-compatible 6.0mm Engaging Ve...
SCANLAN® Easy-Tag™ Tracking System
FDA UDI
SCANLAN INTERNATIONAL INC·00846159033021·Easy-Tag Pre-Printed, Endo Repair, Red 250/Spl
RESPIRATORY BELT SENSOR, MODEL 6000S; LIMB MOVEMENT SENSOR, MODEL 3000S
FDA 510(k)
FDA Class 2
·Anesthesiology
GATIFLOXACIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
FDA 510(k)
FDA Class 2
·Microbiology
BIPOLAR MACRO FORCEPS D:5/ 310MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO KG·Product code GEI·April 6, 2015
BIPOLAR MARYLAND DISS.FCPS 5MM 310MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO KG·Product code GEI·March 9, 2015
JAW INS.BIP.MARYLAND DISS.FEN.5/310MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code GEI·August 29, 2014
JAW INS. BIP.MARYLAND DISS.FEN.5/310MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG.·Product code GEI·January 13, 2015
STEM: SMS SOLID STEM STD SIZE 13
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code LZO·April 29, 2021
MARYLAND GSP.FORCEPS FEN.5/310MM HF CON.
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code GEI·February 19, 2014
JAW INS.BIP.MARYLAND DISS.FEN.5/310MM
FDA Adverse Event
Malfunction
·AESCULAP AG & CO. KG·Product code GEI·August 13, 2015
RESTORE ULTRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·March 13, 2013
ACCU-CHEK ® AVIVA
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code NBW·February 27, 2011
DEXTRUS 4136
FDA Adverse Event
Injury
·BIOTRONIK GMBH AND CO·Product code DTB·February 15, 2008
MARYLAND GSP.FORCEPS FEN.5/310MM HF.CON.
FDA Adverse Event
Malfunction
·AESCULAP, INC.·Product code GEI·August 21, 2015
Item codes starting with 001930 LAG SCR 12.7D X 55MM SHOR up to 155 MM, LAG SCR 12.7D X 55 MM SHO up to 100MM, LAG SCR 12.7D X 55MM STAN up to 155 MM, LAG SCR 15.8D X 55MM LARG up to 155 MM
FDA Recall
Terminated
·Zimmer, Inc.·Product code JDO·October 11, 2013
Item codes starting with 001930 LAG SCR 12.7D X 55MM SHOR up to 155 MM, LAG SCR 12.7D X 55 MM SHO up to 100MM, LAG SCR 12.7D X 55MM STAN up to 155 MM, LAG SCR 15.8D X 55MM LARG up to 155 MM
FDA Enforcement
Class II
·Terminated·Zimmer, Inc.·February 26, 2014
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025